Brief Title
S-1 in Combination With Abraxane in Treating Cholangiocarcinoma
Official Title
Phase II Study of Abraxane Plus S-1 as Second-line Treatment for Cholangiocarcinoma
Brief Summary
This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as
second-line treatment for cholangiocarcinoma.
Detailed Description
There are no standard second-line treatment for cholangiocarcinoma, new therapies are needed.
The efficacy of S-1 as first-line treatment for cholangiocarcinoma was confirmed in several
studies. The IMPACT study showed that Abraxane plus gemcitabine provide better survival than
gemcitabine alone. Since cholangiocarcinoma displayed similar sensitivity to chemotherapy
which was used in pancreatic carcinoma, we assume that S-1 plus Abraxane is effective and
safe in treating cholangiocarcinoma.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rates
Secondary Outcome
Progression-free survival
Condition
Cholangiocarcinoma
Intervention
S-1 plus Abraxane
Study Arms / Comparison Groups
S-1 plus Abraxane
Description: Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
August 2013
Completion Date
December 2017
Primary Completion Date
December 2017
Eligibility Criteria
Inclusion Criteria:
- Histologic or cytologic diagnosis of cholangiocarcinoma
- Not eligible for curative surgery
- Progressed after first-line gemcitabine-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
- No serious or uncontrolled concomitant medical illness
- Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count
≧90,000/ul), hemoglobin: > or equal to 8 mg/dL, total bilirubin: < or equal to 1.5 X
institutional upper limit of normal, calculated creatinine clearance greater than or
equal to 60 mL/min (calculated by the Cockcroft and Gault method).
Exclusion Criteria:
- Uncontrolled infection or severe active comorbid disease
- Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in
situ cervical, bladder or uterine cancer
- Pregnancy or lactating women
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Yuhong Li, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01963325
Organization ID
S1vsNab-P20130819
Responsible Party
Sponsor-Investigator
Study Sponsor
Yuhong Li
Study Sponsor
Yuhong Li, MD, Principal Investigator, Sun Yat-sen University
Verification Date
February 2018